Market authorization of medical products to world markets: the view - - PowerPoint PPT Presentation

Market authorization of medical products to world markets: the view of the Russian manufacturer

Ivan Ozhgikhin President of «IAMT»

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IAMT

The non-profit partnership “International association of developers, producers and users of medical technique” (IAMT) has been established and has been operating since 1991.

Goal:

Combining scientific and industrial efforts to solve issues related to the development of the medical industry.

Objectives:

• Development and approval of the necessary medical industry legislation and regulatory framework;
• Expansion of the Russian and foreign medical market;
• Increasing the competitiveness of manufacturers in Russia and the countries of the EAEU, the CIS;
• Support for manufacturers in the existing market conditions;
• Interactions with government executive and legislative bodies in the field of medical device circulation.

IAMT activities

• Cooperates with the Administration of the President of the Russian Federation, the State Duma, the Ministry of Health,

the Ministry of Industry and Trade, the Ministry of Economic Development of the Russian Federation and other federal authorities in the preparation of National Health Programs, government and departmental programs for the development of the medical industry;

• Coordinates its activities with the Union of Associations and Enterprises of the Medical Industry of the Russian

Federation, the Russian Union of Industrialists and Entrepreneurs and other organizations, including legislative and regulatory support for the medical industry;

• Actively works in conjunction with state organizations of the EEU, CIS and BRICS countries in solving problems of

providing modern, competitive medical products and assists manufacturers in their promotion to the medical market;

• Actively promotes its products to countries in Asia, Africa, Latin America and Oceania through the mechanisms of

bilateral Intergovernmental Commissions;

• It has brought together the most prominent developers, manufacturers of medical devices, service organizations,

associations, more than 100 companies from Russia, Slovakia, Belarus, Bulgaria, Macedonia, and ensures the supply of medical products to healthcare institutions, including a number of high-tech products (more than 8,000 medical products);

• Provides organizational opportunities for the implementation of activities for the training and advanced training of

technical and administrative personnel in the field of production, maintenance and operation of medical devices, the provision of consulting services.

New IAMT Activities

• Analysis of the prospects for the development of the Russian and international market of medical devices, in the light
• f transition to a digital economy and digital health care;
• Making recommendations for the medical industry development strategy based on continuous monitoring of the

market of medical devices;

• Preparation of "road maps" to create new branches of the medical industry and ensure their maintenance;
• Increase in the share of medical devices that can function within the framework of the Unified State Health

Information System and the National Telemedicine System;

• Study of the prospects for creating a unified system for monitoring the functioning of medical devices;
• Development of measures for import substitution of medical products in the Russian market;
• Creating associations of IAMT members to implement large export projects;
• Increase in the share of medical products in Russian non-resource export;
• Joint development with leading Russian and international financial institutions of financial and legal support schemes

for export transactions of IAMT members;

• Creating favorable conditions for national exporters on world markets and in foreign countries.

IAMT core members with positive export experience

«NATIONAL TELEMEDICINE AGENCY»

Research-and-Production Union

Cumulative export experience

• IAMT member companies export to the following countries and unions :

Regulatory practice

• Registration of medical devices is the quality of medical devices, the safety of medical

devices, the effectiveness of medical devices in use;

• Development of high-tech, innovative, safe medical equipment production and promotion on

the world market is possible only by harmonizing regulation of various countries.

Objectives of the Web Portal IAMT (www.medical-device.ru)

In the first quarter of 2015, the IAMT web portal and the Rosmedprom association web portal, which includes the NP IAMT, was put into operation.; Objectives of the Web Portal :

• winning and strengthening the positions of IAMT members and the Rosmedprom

Association on the national and international markets;

• support of work with partners, medical specialists and government agencies, in both

Russia and other countries;

• ensuring the active support of the commercial activities of the members of the IAMT

and the Association, drawing on the authority and experience of these professional associations.

Key m marke kets Scope Fast g growth Low b barriers

• Latin America
• Western Europe
• Eastern Europe (except CIS)
• Middle East and North Africa
• Japan
• South Korea
• China
• Southeast Asian countries
• CIS
• Sub-Saharan Africa

Appealing markets

Market s selection

• n c

criteria

Analysis of the avail ilabil ilit ity of m marke kets f for medical d devic ices f for manufacturers

Problems o

• f medi

dical al p produ ducts export

• The problem of double registration. The company must go through the registration procedure

2 times: according to the national standard and international standard. This problem makes it necessary to train employees according to different standards and delays the implementation

• f projects.
• Various registration schemes. Lack of consolidated information on registration conditions for

medical devices in different countries.

• The problem of uniform standards. In order to integrate local producers into the world market

and increase export potential, the harmonization of Russian standards with world standards is required.

IAMT offers to associations and organizations working in the field of medical device circulation to unite efforts We are looking forward to cooperation. Thank you!